Senior Quality Control Technician

1 week ago

Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

As a vital member of Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Our mission is to empower our customers to enhance health, safety, and environmental standards worldwide. We equip our teams with the necessary resources to achieve their career aspirations while advancing scientific solutions to address some of the most pressing challenges, such as environmental protection, food safety, and cancer research.

Role Overview:

This position is based at our Allentown, PA site, where the Clinical Quality Assurance Inspector will play a crucial role in supporting all quality-related functions associated with the packaging of clinical products through both primary and secondary operations. The role also encompasses commercial packaging activities, requiring close collaboration with management, the quality team, and various cross-functional groups. Strong problem-solving abilities and effective communication skills, both verbal and written, are essential, along with experience in cGMP regulations.

Key Responsibilities:

  • Implement Good Manufacturing Practices (cGMP) across all responsibilities.
  • Promote and embody the company’s vision.
  • Conduct approval of specifications and incoming inspections for materials and distribution shipments.
  • Perform inspections and sampling of materials and processes.
  • Review and approve Packaging Electronic Production Orders.
  • Engage in continuous improvement initiatives and assist in root cause investigations for nonconformities.
  • Author and revise relevant SOPs/Work Instructions, ensuring accurate documentation of activities.
  • Identify and escalate issues that may impact product quality or compliance to the Team Leader and/or Management.
  • Ensure timely resolution of issues and implementation of corrective actions.
  • Execute all tasks in a safe and efficient manner.
  • Additional duties may be assigned as needed to support business objectives.

Qualifications:

Education:

  • Associates degree preferred.
  • High School Diploma or equivalent required.

Experience:

  • A minimum of 2 years of experience in the pharmaceutical or a related regulated industry.

Knowledge, Skills, and Abilities:

  • At least 1 year of experience in a pharmaceutical or regulated environment, along with a High School diploma.
  • Familiarity with Quality Systems, including Change Control, Deviations, Complaint Management, and Documentation Management.
  • Willingness to work in refrigerated (2° C to 8° C) and freezer environments (-20° C) with appropriate protective gear.
  • Flexibility to work various shifts and overtime as required by business needs.
  • Ability to work independently and follow SOPs, Work Instructions, and GMP policies.

Physical Requirements:

  • Significant standing and walking on the packaging floor to monitor activities.
  • Standard work schedule of Monday through Friday, 8 hours per day, with potential for overtime and weekend work.
  • Ability to stand, bend, and lift, with occasional lifting of materials up to 25 lbs and regular lifting of 10 lbs.
  • Exposure to cold temperatures for extended periods.
  • Visual acuity and color perception standards must be met for the inspection of pharmaceutical products, components, and labels.

Benefits:

We offer competitive compensation, an annual incentive plan, healthcare benefits, and a variety of employee perks. Thermo Fisher Scientific provides a dynamic work environment with excellent career development opportunities and a culture rooted in integrity, intensity, involvement, and innovation.

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